Turker 2017.
| Methods | Double blind, randomised controlled trial. 1 emergency department, Turkey |
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| Participants | Inclusion criteria: children aged 3 to 15 years with asthma admitted to the emergency department due to a moderate asthma exacerbation. Exclusion criteria: any associated chronic diseases such as cystic fibrosi and bronchiectasis. 100 randomised. Intervention: 50 randomised. Mean age, months (SD): 76.06 (27.33). Male:female: 25:25. Median (IQR) modified pulmonary index score at presentation 8 (7‐8). Control: 50 randomised. Mean age, months (SD): 74.96 (33.65). Male:female: 29/21. Median (IQR) modified pulmonary index score at presentation 7 (7 to 9). |
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| Interventions | Intervention: nebulised salbutamol (0.15 mg/kg) + 1 mL magnesium sulfate (15%) + 1.5 mL isotonic saline. Control: nebulised salbutamol (0.15 mg/kg) + 1.5 mL isotonic saline. 3 doses given at 20 min intervals. |
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| Outcomes | Primary outcome: Modified Pulmonary Index Score (MPIS); secondary outcomes: hospitalisation rates, symptoms of magnesium imbalance such as nausea, vomiting, abdominal pain, chest pain, headache, fatigue, hypotension and fever. | |
| Notes | Funding: "this research did not receive any specific grant from funding agencies in the public, commercial, or not‐for‐profit sectors". | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | "Patients were assigned consecutively to the control or intervention group based on a stratified randomisation procedure" but no further detail about how the randomisation sequence was generated. |
| Allocation concealment (selection bias) | Unclear risk | Data not given. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Described as "double‐blind" but no details of who was blinded and the blinding procedure. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Described as "double‐blind" but no details of who was blinded and the blinding procedure. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | "All patients enrolled in the study completed it". |
| Selective reporting (reporting bias) | High risk | No trial registration or prospective protocol identified. Adverse events reported as: "no side effect caused by magnesium was observed in any of the patients in the study". Modified pulmonary index score reported numerically at 120 minutes only; other time points presented graphically with no measure of variance |
ASS: Asthma Severity Score (ASS) ATS: American Thoracic Society BP: blood pressure BTS: British Thoracic Society COPD: Chronic obstructive pulmonary disease ED: emergency department FEV1: Forced expiratory volume in 1 second FVC: Forced vital capacity h: hour(s) IV: intravenous MDI: metered dose inhaler MgSO₄: magnesium sulfate PEF: Peak Expiratory Flow Rate R&D: research and development sBP: systolic blood pressure SD: standard deviation SIGN: Scottish Intercollegiate Guidelines Network